Status:
UNKNOWN
Phase 2B Clinical Study of Chondrogen for Treatment of Knee Osteoarthritis
Lead Sponsor:
Meluha Life Sciences SDN BHD
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
Brief Summary
Primary osteoarthritis is a debilitating disease characterized by extensive damage to the joints and excruciating pain leading to loss of activity and depression. Despite advances in diagnosis, the qu...
Detailed Description
Osteoarthritis is one of the commonest diseases in the world, with a global disease burden of 83%. Plain radiograph remained the main modality in diagnosing osteoarthritis. Chondrogen is a mesenchymal...
Eligibility Criteria
Inclusion
- 30-70 years old
- No serious infection, chronic diseases, diabetes and tuberculosis
- Idiopathic or secondary osteoarthritis of the knee with grade 1-3 defined by the modified Kellgren-lawrence classification
- Written informed consents were obtained from all subjects.
Exclusion
- Pregnant or lactating women
- Women of childbearing potential unwilling to use two forms of contraception
- Cognitively impaired adults
- Presence of large meniscal tears
- Inflammatory or post-infectious arthritis
- More than 5 degrees of varus or valgus deformity
- Kellgren Lawrence grade 4 osteoarthritis in two compartments in persons over 60 years of age
- Intra-articular corticosteroid injection within the 3 previous months
- Major neurologic deficit
- Arthroscopy during the previous 6 months
- Poorly controlled diabetes mellitus
- Immunosuppressive or anticoagulant treatment
- NSAID therapy within 15 days prior to inclusion in the study
- Serious medical illness with a life expectancy of less than 1 year
- Prior admission for substance abuse
- Body Mass Index (BMI) of 40 kg/m2 or greater
- Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
Key Trial Info
Start Date :
October 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04520945
Start Date
October 31 2020
End Date
September 30 2022
Last Update
August 20 2020
Active Locations (1)
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1
Department of Orthopedic & Traumatology, Faculty of Medicine, Hospital Canselor Tuanku Mukhriz, UKM Medical Centre, Jalan Yaacob Latiff, Bandar Tun Razak, Cheras, 56000 Kuala Lumpur.
Cheras, Kuala Lumpur, Malaysia, 56000